MAUDE Adverse Event Report: CONTEGO MEDICAL, INC NEUROGUARD IEP SYSTEM; STENT, CAROTID

Model Number	NG-NV-6-40
Medical Device Problem Codes	Off-Label Use (1494); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat carotid stenosis, the physician inserted the neuroguard stent iep system into a 9fr moma cerebral protection device and felt some resistance in the proximal section of the catheter during delivery.The reported devices and accessory devices were prepared as indicated in the ifu.The vessel was not tortuous.The physician took the neuroguard out and the yellow distal tip was not attached.He then removed the moma and it was stuck in it.The devices were removed from the patient, with no surgical or medicinal intervention required.No patient complications have been reported as a result of this event.Additional information was requested and received: lesion/vessel site associated: left ica stenosis, the neuroguard got friection about less that halfway through moma.How was the procedure completed? removed moma and used bmx 96 with neuroguard.Are there any pre-op angios and still images available? unfortunately no.

• Brand Name: NEUROGUARD IEP SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CONTEGO MEDICAL, INC; 3801 lake boone trail,; suite 100; raleigh
• Manufacturer (Section G): CONTEGO MEDICAL; 3801 lake boone trail,; suite 100; raleigh
• MDR Report Key: 25333349
• Report Number: 3011471056-2026-00087
• Device Sequence Number: 13180534
• Product Code: NIM
• UDI-Device Identifier: 00851616007651
• UDI-Public: 010085161600765110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P240009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NG-NV-6-40
• Device Catalogue Number: NG-NV-6-40
• Device Lot Number: Z2461039C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown